Search Results

Oxygen concentration by means of molecular sieve technology, yielding supplemental product oxygen in conformance with official USP designation "Oxygen 93 Percent", and supplemental delivery for oxygen therapy.

Note: The intended use of this system is as a secondary oxygen source. The primary oxygen source for the facility is normally provided by liquid oxygen and distributed in a gaseous state via (typically) 'H' or 'K' supply cylinders in a conventional configuration. (reference: NFPA 99C,1996, fig. 4-3.1.1.6)

FreshAir System

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or any study that proves the device meets specific acceptance criteria. This document is a 510(k) clearance letter from the FDA for a device named "FreshAir System," stating that it has been determined to be substantially equivalent to legally marketed predicate devices.

The document discusses the regulatory classification, general controls, and compliance requirements for the device. It also provides the indications for use. However, it does not contain details about:

• A table of acceptance criteria and reported device performance.
• Sample size or data provenance for a test set.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Sample size or ground truth establishment for a training set.

Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device

Not Found

Not Found

This document is an FDA letter granting 510(k) clearance for the First Medic 710 Oximetry Module. It confirms substantial equivalence but does not contain information about acceptance criteria or specific study details often found in scientific publications or the 510(k) submission itself.

Therefore, I cannot provide the requested information based solely on the provided text. The document is a regulatory approval letter, not a scientific study report.

To answer your questions, I would need access to the actual 510(k) submission (K955890) from Physio-Control Corporation, which would contain the clinical data, acceptance criteria, and study details.

Ask a specific question about this device